Job Description

Responsibilities :\xef\x83\x98 Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.
\xef\x83\x98 Candidate will be accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents.
\xef\x83\x98 Candidate must have fair conceptual understanding on below key areas
o IT QMS
o Validation/Qualification
o Risk management.
o Handling of defects/Deviations
o Investigations
o CAPA Handling
o Test Management & Compliance
\xef\x83\x98 Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
\xef\x83\x98 OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
\xef\x83\x98 PAS/DCS Qualification
\xef\x83\x98 ISA95 High level of understanding
\xef\x83\x98 OT Security will be a plus.
\xef\x83\x98 Standalone Systems Qualifications
\xef\x83\x98 PAS/DCS Integrated with Manufacturing Equipment qualification.Additional Responsibilities :\xef\x83\x98 Hands-on experience on testing tools like HP ALM, Kneat and SNOWTechnical and Professional Requirements :3+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
\xef\x83\x98 Well versed with Manufacturing, Quality and engineering system and their validations
\xef\x83\x98 Stakeholder management and good executor with required communication.
\xef\x83\x98 Knowledge of Pharmaceutical / Life Sciences as domain.
\xef\x83\x98 Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage
- OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
- PAS/DCS Qualification
- ISA95 High level of understanding
- OT Security will be a plus.
- Standalone Systems Qualifications
- PAS/DCS Integrated with Manufacturing Equipment qualification.Educational Requirements :Master of Pharmacy,Bachelor of Pharmacy (Honors),Bachelor of Engineering,Bachelor Of Technology,Bachelor Of Science,Master Of TechnologyService Line :Application Development and Maintenance

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